Archive for the ‘Pharma’ Category

Book Note: Anatomy of an Epidemic – worse still

It’s time to move on to another topic. Two books in a row about psychiatry and what has become of it due to the influence of pharmaceuticals is quite enough for me for a while. This book, though, is one that cannot be ignored:

Anatomy of an Epidemic: Magic Bullets, Psychiatric Drugs, and the Astonishing Rise of Mental Illness in America [Hardcover]

It would be easy to lump this book together with Unhinged, Dr. Daniel Carlat’s book about this same issue from the perspective of a clinician. In fact, though, it addresses the issue from a different perspective.

Mr. Whitaker takes a wider, more epidemiological view and comes up with what can only be taken as a shocking conclusion: the central cause of the ballooning of psychiatric conditions over the last 50 years (anxiety disorders, bipolar, depression, ADHD) is the drugs themselves. That’s right, the drugs are causing the epidemic, not environmental toxins or video games or reality TV.

He comes to this conclusion by viewing the outcomes of patients who have been administered a host of psychiatric drugs over long periods of time. As it turns out, this distinction is key. Why? Because the clinical trials that are used to ensure that drugs are safe to be administered are typically (in the case of psychiatric drugs, always) trials of a short-term nature (six to eight weeks). What happens to people who are on these drugs for months? Years? Well, this book cites studies that have chosen to answer that very question and found that, in comparison to control groups who were not on the drugs long-term, those who stay on the drugs are worse off.

That said, I have to admit a fair amount of skepticism about all the clams in the book, so I would not take the entire message hook, line and sinker. But the core message: use of these drugs as long-term, chronic treatment actually makes things worse, is enough to get your head spinning.

As is my wont, here are a few links to audio interviews of the author also:

Need to Know on PBS
Medication Ethics Seminar
At Powell’s Books in Portland, OR
Video of Powell’s Books appearance

Gotta go now. I think I’m gonna be sick.

Book Note: Unhinged – Could it get any worse?

Recently completed a fascinating book by Dr. Daniel Carlat: Unhinged The Trouble with Psychiatry – A Doctor’s Revelations about a Profession in Crisis. 

Unhinged: The Trouble with Psychiatry – A Doctor’s Revelations about a Profession in Crisis

If you’ve seen my thoughts in a previous post about Dr. Barbara Angel’s book The Truth About the Drug Companies, much of what Dr. Carlat has to say will be familiar to you. What is noteworthy about this book, though, is that he recounts his experience as, essentially a Dr. Drug Rep for Wyeth (now part of Pfizer). In it you’ll find how the profession psychiatry has been utterly co-opted the pharmaceutical companies. Also for an eye-opening look at how some in the medical profession have sold out their patients, read Carlat’s article linked to above in the NYT Magazine.

Now with all this pharma-bashing, you’d think I’m just offering to rid the world of this scourge. Please understand that I am not. However, the practices that have been exposed time and time again have to stop. The first essential step in the process is for medical profession regains its professionalism in this regard (see Dr. Arnold Relman’s A Second Opinion). The other thing that has to happen is we as patients need to be better informed so we are able to look out for best interests. Be sure to ask the important questions about any drugs that are prescribed to you.

Oh, if you’re not so much into the reading thing, there’s an interview of Dr. Carlat from Fresh Air which was broadcast in July 2010.

Don’t Believe This – Kids on statins

[Pissing+child.jpg]One of the most disgusting ideas I’ve come across in following medical issues is this idea that children might be prescribed stating drugs. This unwelcome thought was triggered anew with today’s article and featured video.

"All kids need cholesterol tests" the headline blares. 

"Tens of thousands of children could benefit from medication" thus spake the oracle.

The very idea of widespread screening of children for the purpose of getting them on a lifelong regimen of statin drugs is absolutely revolting.

The underpinnings of the lipid hypothesis *in adults* has all but completely crumbled (http://thehealthyskeptic.org/images/statintrialsummary.pdf) and now we get the pharmaceutical companies floating this idea of extending the flawed hypothesis to children where there is *NO* clinical evidence proving benefit.

Recently read The Truth About the Drug Companies by Marcia Angell, here’s my recent post on it. One of the little anecdotes Dr. Angell recounts leaps to mind immediately. She published an article in the New England Journal of Medicine some years ago posing the rhetorical question "Is Medical Education for Sale?" The most telling answer came from a reader who I paraphrase: "No, of course it is not for sale. The present owner is quite happy with it!"

When you see articles like this one, remember who’s truly in the ownership position here.

Preventative use of statins

Upon starting this blog, there were a number of concerns that came to mind. Would I run out of things to talk about? Would anybody listen/care? Would my opinions just come off as silly? (‘not yet,’ ‘enough, it seems,’ and ‘too early to tell’ are the answers as far as I can tell to date). But it really didn’t occur to me that I’d come off as the crotchety, perpetually peeved, quixotic nutcase (ok, it did occur to me but I didn’t want to let it in). My fear is that this ‘just below the surface’ tendency might come into sharp relief when I take on the subject of statins.

Quick primer on statins to the 5% my readers not old enough to have had this modern medical miracle come into their consciousness. Put simply, statins are a class of pharmaceutical drugs that focus on limiting the synthesis of cholesterol in the blood based on the premise that it is the presence of high concentrations of cholesterol (low-density lipoprotein, to be more precise) that is the primary causative risk factor for atherosclerosis (or ischemic heart disease) which leads to heart attacks and brain attacks (strokes).

More recently, the clever folks who brought you endless lifestyle drug commercials (with their sometimes howlingly funny litany of side effects) have come up with the bright idea that these miracle statins should be prescribed to an enormous swatch of human population. I find the very idea of this more than a little disturbing. First off, the entire premise upon which the ‘lower cholesterol to reduce heart attacks’ premise is highly questionable (see The International Network of Cholesterol Skeptics for more). Secondly, the proof for the effectiveness of statins is limited to a relatively small set of patients (primarily men under 65 who have already had heart attacks). Thirdly, the just-recently observed side-effect of statin use that reduces inflammation (as measured by C-Reactive Protein) has never been studied as an independent factor.

More recently, though, a spate of clinical trials has called the whole game into question. Thanks to a fantastic synopsis at the Healthy Skeptic blog, there’s a one-page summary that tears down the presumptions that statins are clinically useful. It’s an extremely important reference when having that all-important discussion with your doctor about statins. To say nothing of the many side-effects common with statins and that we don’t have any conclusive data about long-term use of statins (which seems important given they are being prescribed *for life*).

Now comes the all-out pressure to allow for prescribing statins as ‘preventative’ measures in a wide swath of the population.

Please be extra vigilant if your doctor proposes putting you on a statin. Educate yourself and ask really probing questions before just taking what you’re being told at face value.

Better to use diet and exercise the obviate the need for these hazardous drugs all together.

Book Note: The Truth About the Drug Companies

Just completed a book I’ve been meaning to get to for some weeks

The Truth About the Drug Companies: How They Deceive Us and What to Do About It

While it’s gotten to be pretty easy to pick on the pharmaceutical industry of late, this laser-focused book does more than just lob a few broadsides. It pretty much eviscerates every one of the major arguments put forth by the pharmaceutical industry for their practices.

The author is Dr. Marcia Angell, who has had a front-row seat having worked on the staff of the New England Journal of Medicine for 20 years – winding up her career there as Editor In Chief in the late ‘90s. It’s hard to over emphasize the gravity of someone of Dr. Angell’s experience and stature writing a book like this that, as far as I can tell, doesn’t pull a single punch. I suppose it shouldn’t be an enormous surprise, She is married to Dr. Arnold Relman whose book A Second Opinion does much of the same for the entire practice of medicine in the US.

A Second Opinion: Rescuing America’s Health Care

Though this book is kinds long-in-the-tooth by medical policy issues standards (having been published in 2004) it’s not just a little depressing to note that the fundamentals haven’t changed (although, I should be fair and note that there have been some changes in the margins – will get to those in a bit)

So, what are the big takeaways, just in case you don’t read the book :). Well, here are a few:

  • By any objective measure, pharmaceutical companies pay *at least* twice as much for marketing and promotion of their products as they do for research and development of products. It might do well for you to really take that in. An industry that constantly bombards you with the holier-than-thou pronouncement of the centrality of their products to life itself, spends at least twice as much in marketing and promotions than it does for the actual science.
  • ‘Education’ to physicians and other care providers, is actually nothing more than a form of marketing. Everyone knows this but most choose to remain silent and play along
  • ‘Research’ (i.e. many of the clinical trials used to tout the capabilities of drugs) are nothing more than marketing in disguise. This is especially the case for the ‘Phase IV’ trials that take place after a drug has come to market. These trials are almost exclusively biased towards enabling the results to be used as marketing and promotions fodder – not for the purpose of actually determining the effectiveness of the drug or comparing its effectiveness with other treatments.
  • The price-fixing of the cost of drugs in the US (brought to you by millions of dollars in lobbing might heaped on your local legislators) is a putrid, steaming pile of excrement that is hard to believe those in charge sit in every day without expiring from the fumes.

Now, to be clear, I’m clearly not against pharmaceuticals, per se. We are able to live longer, healthier lives because of the breakthroughs in pharmaceuticals. There is a point at which one has to ask: are the benefits that are accruing to us now worth the cost?

Not only does Dr. Angell lay it on pharma, she also makes a few, common-sense suggestions for you, the consumer, to consider when encountering the medical care system:

When your doctor prescribes something, ask:

  • Where’s the evidence this works at all, or better than another, older, drug?
  • Are you getting your ‘evidence’ from the pharma rep, or was there an independently-funded, well-designed clinical trial that proved it was better?
  • Do you have any financial ties related to the prescription?

Other tidbits:

  • Ask your elected representatives if they receive contributions from the pharmaceutical industry.
  • Ignore direct-to-consumer ads for prescription drugs.

Be very afraid … of vitamins!

Scary, huh?Seems every major media outlet has to have an obligatory ‘be afraid of vitamins’  article/editorial periodically. It’s almost as if the folks a PhRMA have a database to keep track of this stuff:

PhRMA Rep Dude: Hello newspaper/TV/radio Publisher Guy. We noticed that, even though our members have booked an obscene amount of direct-to-consumer pharmaceutical ads with your company, we notice you have not recently scared the electrolytes out of your readers/viewers by telling them the will die if they take vitamin C.

Publisher Guy: Oh, my apologies, PhRMA Rep Dude, we’ll get right on it. In fact, we have a set of stock editorials from which we pull this content to publish periodically. What with all the terror scares, economic re-meltdown, deadly earthquakes/aftermaths, mortgage crisis, undersea oil gushers and Jon & Kate news, it must have slipped off the queue momentarily. Rest, assured, we’ll get that one up right away.

PhRMA rep dude: You would do well to make good on this, Publisher Guy. You know we’re subsidizing the last two ‘real news’ reporters on staff. Hop to it.

So what’s got me spinning out on a random association tangent today? This ‘editorial’ in USA today:

Our view on pills and potions: Do you really know what’s in that dietary supplement?
http://www.usatoday.com/news/opinion/editorials/2010-06-07-editorial07_ST_N.htm

Here’s a fun little tidbit:

Researchers at an accredited lab working for Congress’ non-partisan Government Accountability Office recently found traces of potentially hazardous contaminants in almost all of the 40 supplement products tested.

“Mommy, Mommy, please protect me from that scary Vitamin E.”

It did not escape my notice that in this very same issue (6/8/2010), there were several ‘news’ articles extolling the virtues of the latest pharmaceutical drug that may extend life about four months if you (well, we mostly) spend about $30,000/month for the drug.

Let’s have a few numbers for perspective. Way back in 1999, the Institute of Medicine published a landmark book called To Err is Human. In it, among other things, it cited 98,000 deaths in the US caused by medical care. To be clear, this was not the total number of deaths from all causes, these were deaths directly attributable to contact with the medical care system. While the book did not tease out how many of these deaths were specifically related to adverse drug reactions (ADRs), it is well understood that ADRs are a significant contributor.

More recently (in 2008), in a study published in the British Journal of Clinical Pharmacology (note: not published in the US) It is estimated 3% of all deaths in the general population of industrialized countries are as a result of adverse drug reactions. In the US, the conservative estimate puts us at about 70,000 deaths per year directly related to legal pharmaceutical drugs (total of 2.4 mm deaths/year in US). Contrast this with the number of deaths from vitamins/supplements (namely, –0- in the typical year) and it’s not hard to see that we have our scary headlines misplaced.

What I find even more remarkable is how little information there is out there that probes the issue of the safety of pharmaceuticals in aggregate. You’d think that if the Institute of Medicine estimates some large number of people are killed by sanctioned, ‘on-label’ use of pharmaceuticals, we would have studied it more, here eleven years on. The silence is deafening, to borrow a shop worn cliché.

Here is your takeaway: the next time you see the “What about the health risks of vitamins” headline (and, make no mistake, you will see them popping up like clockwork), remember two numbers: *70,000* and *0*.

Book Note: Know Your Chances: Understanding Health Statistics

Know Your Chances: Understanding Health Statistics

While there may be more thoroughly-investigated and references books on the topic of understanding health statistics, I find this one the most accessible. At a very light 130 pages (lots of tables, pictures and charts) it’s an extremely quick read and gets to the heart of the matter. That heart is “Don’t get flummoxed by misleading health ads.”

The very patiently and cogently explains the difference between absolute risk (Zocor reduces the chance of death from heart attack by 42%) and relative risk (Zocor reduces the chance of death from heart attack from 8.5% to 5%).
Of course, this could be applied to well-meaning public service announcements meant to scare us into action as well.

The authors have been taking the lead to get the US FDA to require a “Drug Facts Box” for all direct-to-consumer print advertising. Such a box would not just include the most favorable way of describing clinical results (see above) it would also require the maker to list the common side effects and their likelihood as well. It would be a big step in the right direction. To get background on their work, take a look these two reports:

Highly recommended due to it’s ‘punch per page.’
(2/10)

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